Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease

NCT ID: NCT06772220

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-12-31

Brief Summary

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This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.

Detailed Description

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Conditions

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Parkinson&Amp;#39;s Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Study participants with elevated homocysteine levels at the first study visit will take B vitamins for 3 months, and then have a follow-up visit. Study participants with normal homocysteine levels at the first study visit will not take the B vitamins, and will also have a follow-up visit 3 months later.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B vitamin regimen

Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.

Group Type EXPERIMENTAL

Folic Acid 1 MG

Intervention Type DIETARY_SUPPLEMENT

Folic Acid 1mg per day

Vitamin B6 25 MG

Intervention Type DIETARY_SUPPLEMENT

Vitamin B6, 25mg per day

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

Vitamin B12, 1,000 ug per day

No vitamins

No vitamin intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Folic Acid 1 MG

Folic Acid 1mg per day

Intervention Type DIETARY_SUPPLEMENT

Vitamin B6 25 MG

Vitamin B6, 25mg per day

Intervention Type DIETARY_SUPPLEMENT

Vitamin B12

Vitamin B12, 1,000 ug per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.
2. Currently treated with levodopa at a minimum dose of 300 mg/day
3. Montreal Cognitive Assessment (MOCA) ≥15
4. Demonstrated capacity to provide informed consent.
5. 40-90 years of age
6. Estimated glomerular filtration rate ≥60
7. Absence of uncontrolled hypertension in medical history
8. Absence of insulin use

Exclusion Criteria

\-
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Joseph Quinn

OHSU Parkinson Center Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Quinn, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health & Science University (OHSU)

Locations

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Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Madeline Armendariz Sullivan

Role: CONTACT

503-501-8478

Facility Contacts

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Madeline Armendariz Sullivan

Role: primary

503-501-8478

Other Identifiers

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PF-CER-979199

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB 25171

Identifier Type: -

Identifier Source: org_study_id

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